Methylergonovine Maleate

Product NDC: 0054-0639
11-digit product format: 000540639
Labeler code: 0054
Product ID: 0054-0639_70106231-37f6-3e64-e053-2991aa0ab9af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylergonovine Maleate
Dosage form: TABLET
Route: ORAL
Labeler: West-Ward Pharmaceuticals Corp
Application: ANDA210424
Marketing category: ANDA
Marketing start: 2018-07-03
Marketing end: 0000-00-00
Substance: METHYLERGONOVINE MALEATE
Active strength: 0 mg/1
Pharmacologic classes: Ergolines [CS],Ergot Derivative [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0054-0639		D	Discontinued by firm	2026-10-16
excluded package	package	0054-0639	0054-0639-03	D	Discontinued by firm	2026-10-16
excluded package	package	0054-0639	0054-0639-05	D	Discontinued by firm	2026-10-16
excluded package	package	0054-0639	0054-0639-13	D	Discontinued by firm	2026-10-16
excluded package	package	0054-0639	0054-0639-25	D	Discontinued by firm	2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0054-0639-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0054-0639-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0054-0639-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0054-0639-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0054-0639-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0054-0639-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0054-0639-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0054-0639-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0054-0639-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0054-0639-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0054-0639-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0054-0639-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0054-0639-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0054-0639-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0054-0639-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0054-0639-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0054-0639-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0054-0639-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0054-0639-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0054-0639-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0054-0639-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0054-0639-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0054-0639-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0054-0639-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0054-0639-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0054-0639-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0054-0639-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0054-0639-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0054-0639-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0054-0639-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0054-0639-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0054-0639-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0054-0639-13	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0054-0639-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0054-0639-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0054-0639-03	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210424-001	METHYLERGONOVINE MALEATE	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB		2018-05-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A210424-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210424-001	METHYLERGONOVINE MALEATE	0.2MG	TABLET / ORAL	AB	2018-05-15	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A210424-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210424-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210424-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210424-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0639-05	EA - Each	0054-0639	67eb53ff-3b2b-46bc-b8e2-8d2a05b407b6	1	2018-08-13
0054-0639-13	EA - Each	0054-0639	9c16ccbf-4043-466c-88f2-201f86539f4c	1	2018-08-13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylergonovine Maleate	METHYLERGONOVINE MALEATE	Major Pharmaceuticals	c7f19e89-8b52-4033-9914-f3b41fe0790d	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210424 application number: ANDA210424

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
IR84JPZ1RK	METHYLERGONOVINE MALEATE	57432-61-8	METHYLERGONOVINE MALEATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0639-03	00054063903	7 TABLET in 1 BOTTLE (0054-0639-03)	7 tablet	2018-07-03	0000-00-00	No	No	Current
0054-0639-05	00054063905	12 TABLET in 1 BOTTLE (0054-0639-05)	12 tablet	2018-07-03	0000-00-00	No	No	Current
0054-0639-13	00054063913	28 TABLET in 1 BOTTLE (0054-0639-13)	28 tablet	2018-07-03	0000-00-00	No	No	Current
0054-0639-25	00054063925	100 TABLET in 1 BOTTLE (0054-0639-25)	100 tablet	2018-07-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylergonovine Maleate Tablets, USP Rx Only	West-Ward Pharmaceuticals Corp	2024-12-04	HUMAN PRESCRIPTION DRUG LABEL	3
Methylergonovine Maleate Tablets, USP Rx Only 8441094/0918F	American Health Packaging	2024-01-24	HUMAN PRESCRIPTION DRUG LABEL	4